Catalog Number

-

Brand Name

Cypress

Version/Model Number

25-94

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LYZ

Product Code Name

Vinyl Patient Examination Glove

Public Device Record Key

d09b182b-695e-4659-a973-3674af270371

Public Version Date

May 28, 2020

Public Version Number

1

DI Record Publish Date

May 20, 2020

Package DI Number

20815555020489

Quantity per Package

10

Contains DI Package

10815555020482

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case